RESPINOR AS Successfully completed Private Placement of approx. NOK 20 million (€ 2,0 million)

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The Company’s Board of Directors is pleased to announce that the Private Placement led by our financial advisor Corpura Fondkommission AB has been successfully completed, raising of approx. NOK 20 million (€ 2,0 million) in gross proceeds.

The net proceeds from the Private Placement will enable the completion of the ongoing clinical evidence study DE-RISK WF in France, Italy, and Norway. In addition, the proceeds will be used for the continued DXT product development to reach the design freeze, including CE mark submission to secure product launch by Q4-2022.

RESPINOR is working together with Corpura Fondkommission as our financial advisor and intends to list the Company’s shares at a stock exchange in Sweden during the beginning of 2022.

Trude Tingvoll, CEO of RESPINOR, said: “I am grateful for the commitment to the Company from our existing investors and from new Swedish investors that have joined the Company. We are now accelerating the process towards an IPO after a successful product development, where the clinical utility of RESPINOR DXT is documented. With our breakthrough technology, DXT, we aim to secure patients are liberated from the ventilator at the right time when the breathing muscle/diaphragm is strong enough to enable patients to breathe by themselves. I am proud to help these critically ill patients with an easy-to-use technology that will change respiratory health forever”.

About RESPINOR:

RESPINOR AS was founded in 2015 and is a Norwegian MedTech company. The Company is developing a new, non-invasive, ultrasound-based medical device to monitor the diaphragm, the main respiratory muscle, continuously. This is the first ultrasonic sensor that can be attached directly to the patient’s skin to ensure that they are taken off the respirator at the right time when the diaphragm is strong enough for patients to breathe by themselves. The technology has a wide range of potential benefits in several areas, and the Company’s product, based on this technology, is called RESPINOR DXT. The Company’s technology is, among other things, the winner of Horizon 2020 financing, both in phase I and II, and also won the Nordic Life Science Invest Rising Star Awards in April 2021 in the MedTech/Diagnostics category. RESPINOR has successfully completed clinical feasibility studies in Europe (France, Italy, and Norway) for the first target segment, mechanical ventilation, with technical proof of concept and proof of principle confirmed. RESPINOR has currently an ongoing clinical evidence study, DE-RISK WF, which began in April 2021, where they also include COVID-19 patients and is well underway with recruitment.

 

For further information, please contact:

Trude Tingvoll, CEO of RESPINOR AS

E-mail: t.tingvoll@respinor.com

Cell: +47 474 53 313

RESPINOR has started the last phase of the clinical program, DE-RISK-WF study in Europe, with DXT before regulatory submission (EU and USA)

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A multicenter, multinational clinical evidence study, including COVID-19 patients, to validate RESPINOR DXT’s performance to identify patients at increased risk of weaning failure (ClinicalTrials.gov ID: NCT04696406). RESPINOR has secured NOK 14.2M in soft funding from the Research Council of Norway to perform this study and to support our development to secure that our breakthrough technology, RESPINOR DXT, will be available for critically ill patients on mechanical ventilation worldwide.

The aim is to develop predictive indices to optimize the time patients are on mechanical ventilation (MV) by establishing cut-off values ​​to predict weaning outcome. DXT has the potential to optimize extubation timing, reduce re-intubation rate, improve patient outcomes, and reduce healthcare costs.

COVID-19 is arguably the worst pandemic the world has seen in 100 years and has caused more than 75 million cases and 1.6 million deaths worldwide as of mid-December 2020. It is deeply disrupting our health and socio-economic systems and provoking severe shortages of MV capacity, prompting an urgent need for accelerating the development and spread of technologies that can reduce the strain on these resources.

In 2020, RESPINOR finalized feasibility studies with proof of concept and technical proof of principle confirmed. The results were presented at the American Thoracic Society (ATS) International Conference 2021 (see link for abstract: https://www.atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2021.203.1_MeetingAbstracts.A2766). In the feasibility studies, we identified a threshold value of 1.1 cm for weaning outcome. Now, we will confirm this threshold in the newly started Clinical Evidence Study:

  • Primary endpoint: Difference in the rate of weaning failure between patients with a diaphragm excursion (DE) < 1.1 cm compared to those with a DE > 1.1 cm. Median DE measurements taken during the second minute of the SBT will be used in the analysis to ensure that we identify ventilator-induced diaphragm dysfunction early. The hypothesis is that patients with DE < 1.1 will have a significantly higher rate of weaning failure compared to those with a DE > 1.1. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.

Clinical application: If DE < 1.1 cm at time of weaning, the risk of weaning failure is increased due to the fact that the diaphragm has gotten too weak to enable the patient to breathe on their own. The physicians can now initiate rehabilitation of the diaphragm prior to weaning.

The study is expected to be completed in Q4 2021, following the planned product launch in Q4 2022.

Investigator team at Oslo University Hospital, Rikshospitalet. From the left: Andreas Barratt-Due (assistant head of department), Kine Green Pedersen (ICU nurse), Jon Narum (anesthesiologist), and Ingrid Dannevig Landsverk (anesthesiologist and PI). ICU nurse Siri von Krogh is the patient. Courtesy of OUS by Hedda Holth.

RESPINOR:

RESPINOR is a Norwegian MedTech company developing a novel, non-invasive, ultrasound-based medical device for continuous monitoring of the diaphragm, the main breathing muscle. The technology has a wide range of potential benefits in critical care and respiratory medicine,  and the company’s first product is called RESPINOR DXT (“DXT”). The company’s technology has twice been ranked the winner of Horizon 2020 funding, both in Phase I and II, and won the Nordic Life Science Invest (NLSInvest) Rising Star Awards in the Medtech/Diagnostics category in April 2021. The company has successfully completed clinical feasibility studies in Europe for the first target patient segment on mechanical ventilation (MV) with technical proof of concept, and proof of principle confirmed. RESPINOR has recently started a multicenter, multinational clinical evidence study, including COVID-19 patients.

High medical need:

MV is one of the most common therapies in the intensive care unit (ICU). It is treatment patients only receive in the most life-critical situations. Every extra day a patient is on MV the risk of permanent damage to the breathing abilities increases along with the treatment costs. It is, therefore, vital that patients on MV return to normal breathing as quickly as possible. There is currently a lack of predictive, accurate, and cost-effective solutions to support this process – and the introduction of new technologies is highly warranted. After extubation or liberation from the ventilator, breathing difficulties and respiratory failure can often be directly linked to diaphragm dysfunction.

In today’s clinical practice, diaphragm monitoring is not routinely performed, which means that diaphragm dysfunction often goes unnoticed. The introduction of DXT represents a paradigm shift. Annually, 4.5 million patients are treated with MV in the EU and US, costing the healthcare system €35 billion. The introduction of DXT will provide an objective measure of diaphragm function, to ensure that patients are liberated from the MV at the right time. If 10% of patients can be extubated just 1 day earlier, this represents a cost saving of €727 million per year, while providing significantly improved hospital care.

Problems with current methods: 

There is a significant unmet medical need to improve the weaning or liberation process from MV. And the rapid spread of COVID-19 is provoking severe shortages of MV capacity, prompting an urgent need for solutions that can reduce the strain on these resources. If the patients are too long on MV, the risk of permanent damage to their breathing ability increases. However, if they are extubated too early, they risk reintubation. The risks associated with reintubation are severe, including prolonged length of MV support, increased mortality, and increased costs to both the hospital and society. With today’s standard of care, as many as 30% of patients are re-intubated. The introduction of RESPINOR DXT will provide an objective measure of diaphragm function, to assist the specialists in determining when the patient can be liberated from the MV without complications.

 

Interview: The winners of the NLSInvest Rising Star Award

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Fransisco Rojas, Michael Rutzler and Trude Tingvoll
Photo of Francisco Rojas, Business Development Manager, RetinaRisk, Michael Rutzler, CEO, ApoGlyx and Trude Tingvoll, CEO, Respinor

The three Rising Stars, Swedish ApoGlyx, Norwegian Respinor and Icelandic RetinaRisk, share their companies’ histories and journeys so far and also, their advice to other life science entrepreneurs.

Following a long review of the applications by a pan-Nordic committee of industry leaders, 80 Rising Stars were selected to pitch to investors across three dedicated tracks: biotech/pharmamedtech/diagnostics and digital/e-health. One company from each track was selected as the category winner during the NLSInvest event, April 19th.

The “best of the best” of our entrepreneurs

This year’s NLSInvest Rising Star Awards are sponsored by SwedenBIO and BioInnovation Institute (BII), an international life science entrepreneurship initiative and part of the NLSInvest Committee.

“We believe the Nordic ecosystem has all the ingredients required for success and are happy to see international investor interest in the NLSInvest Rising Star companies. Our view is that high-growth Nordic start-up companies must play on a global playing field, and the Rising Star Award is a step in that direction. We wish the participants and the winners of the competition continued success,” says Bobby Soni, Chief Business Officer at BioInnovation Institute.

“We look upon this as the Olympics of life science innovation, where each Nordic country’s strength in this field is proudly demonstrated by the “best of the best” of our entrepreneurs,” says Helena Strigård, CEO of SwedenBIO, the Swedish Life science Industry organization and host of NLSInvest / NLSDays.

For full Interview profiling RESPINOR, follow the link: https://nordiclifescience.org/interview-the-winners-of-the-nlsinvest-rising-star-award/

RESPINOR Announced Winner at the Nordic Life Science Investment Days

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Over 150 Nordic companies applied to the launch of the first-ever Nordic Life Science Investment Day, NLS Invest. Following a long review of the applications by a pan-Nordic committee of industry leaders, 80 Rising Stars were ultimately selected to pitch to investors across three dedicated tracks: biotech/pharma, medtech/diagnostics and digital/e-health.

From the 80 Rising Stars, one company from each track was selected as the category winner, and RESPINOR was announced winner of the Medtech/Diagnostics tracks. See the full press release in the link below:

https://press.swedenbio.se/posts/pressreleases/apoglyx-respinor-and-retinarisk-announced-as

Kitron and RESPINOR in MedTech partnership

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Kitron and RESPINOR AS have entered into a strategic long-term agreement. Kitron will be providing manufacturing and technical services as RESPINOR is getting ready for commercial manufacturing of its breakthrough technology: RESPINOR DXT. This is the first ultrasound-based sensors that can stick to the skin to provide continuous monitoring of our main breathing muscle, the diaphragm, leading to improved Intensive Care Unit (ICU) patient outcomes and shorter patient stays.

“Kitron and RESPINOR have already cooperated on prototypes, and this new agreement forms a solid platform for industrialization and ramp-up to make RESPINOR DXT available for critically ill patients worldwide,” said Trude Tingvoll, CEO of RESPINOR.

“Kitron has a long track record of helping customers convert ideas into manufacturable technology products, and we specifically look for companies with substantial growth potential. RESPINOR’s products will have an immediate positive impact on patients in ICU’s. This is especially relevant in these Corona fighting days, but also in the long term”, said Israel Losada Salvador, COO & Chief Sales Officer of Kitron.

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RESPINOR awarded 14.2M NOKs from the Research Council of Norway

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Christmas arrived early! We are pleased to announce that RESPINOR has secured 14.2M NOKs in soft funding from the Research Council of Norway to perform our pivotal study (DE-RISK WF) which will commence in Q1-2021! This will take us one step further to secure that our breakthrough technology, RESPINOR DXT, will be available for critically ill patients on mechanical ventilation world wide.

Thank you to the Research Council of Norway for supporting innovation in Norway within MedTech!

https://www.forskningsradet.no/nyheter/2020/forskningsradet-investerer-602-millioner-kroner-i-mer-innovasjon-i-naringslivet/

RESPINOR winner of the European Innovation Councils (EIC) ePitching event for COVID-19 solutions

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COVID-19 is deeply disrupting our health and socio-economic systems and provoking severe shortages of MV capacity, prompting an urgent need for accelerating the development and spread of technologies that can reduce the strain on these resources. The European Innovation Council (EIC) brought together over 50 public and private procurers, five European corporates, and more than 20 EIC-backed SMEs for an EIC ePitching on COVID19-solutions. We are excited to share that RESPINOR was announced the winner of the ePitching session with RESPINOR DXT – That provides an objective and continuous measure of diaphragm function, hence improves clinical decision-making in critically ill patients’ weaning readiness from mechanical ventilation. More information about the event can be found here: https://community-smei.easme-web.eu/articles/eic-epitching-procurers-covid-19-finding-common-solutions-together

 

 

First patient enrolled in RESPINOR’s mechanical ventilation WEAN-US study at Hospitalier Pitié-Salpêtrière in Paris, France.

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The study Principal Investigator, Prof. Alexandre Demoule, with the study equipment including RESPINOR DXT and pressure measuring hardware.

Study title: Improvement of weaning from mechanical ventilation by continuous ultrasound monitoring of diaphragm excursion: the WEAN-US Study.

The objective of the study is to evaluate the feasibility of “RESPINOR DXT” for continuous monitoring of diaphragmatic excursion in patients undergoing mechanical ventilation in intensive care, to validate these measurements by comparing them with standard ultrasound data as well as transdiaphragmatic pressure measured simultaneously and to establish a link between diaphragmatic excursion and the outcome of weaning from mechanical ventilation.

Our hypothesis is that the continuous measurement of the right hemi-diaphragmatic excursion by the RESPINOR DXT device is feasible, reliable and that there is a statistical link between the amplitude of this excursion and the success of withdrawal from mechanical ventilation.

RESPINOR AS: A Norwegian medical device company founded in 2015 based on IP, prototypes and clinical development at the University of Oslo and NeoRad AS. RESPINOR is developing an objective measure of breathing for critically ill patients within intensive care. RESPINOR DXT (Diaphragm Excursion Technology) is non-invasive, easy to use and provides precise, real-time continuous monitoring of the diaphragm function, our main breathing muscle. Monitoring the up-and-down movement of the liver, RESPINOR DXT measures diaphragm excursion using the liver as a proxy for the motion of the diaphragm. The monitoring of the diaphragm may provide useful information to guide clinical decision making in patients with respiratory dysfunction. RESPINOR DXT was twice ranked number one in the European Commission’s Horizon 2020 program, both in phase I and phase II, addressing an unmet medical need because every breath counts.

Currently, the company has initiated clinical observational studies in Europe (Norway, France, and Italy), which will lead to a multinational multicenter study for the first indication in mechanical ventilation (MV).

RESPINOR’s technology has a broad range of potential benefits and represents an enabling technology platform for application in critical care and other areas of respiratory medicine.

Mechanical ventilation (MV): Patients are placed on invasive MV because they are unable to sustain breathing on their own in such a way as to maintain sufficient gas exchange (oxygen uptake, carbon dioxide elimination). The most common underlying clinical conditions that are associated with acute respiratory failure and the subsequent need for MV include postoperative respiratory failure, neurologic disease, pneumonia, chronic obstructive pulmonary disorder (COPD), congestive heart failure, and sepsis.

However, MV is associated with a number of complications including muscle atrophy (shrinkage due to underuse) and muscle fiber damage related to increases in protein breakdown caused by unloading of the diaphragm as the ventilator assumes control of respiration, pneumonia, and lung injury due to excessive pressure or volume of air forced into the lungs by the ventilator. The process of diaphragm muscle fiber damage and atrophy has been shown to begin as soon as within 3-4 days of commencing MV.

As such, the intensive care clinician must balance the need for MV to maintain adequate gas exchange with getting the patient off the ventilator as soon as possible (a process known as “weaning”) so as to avoid diaphragm dysfunction.